Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (NCT NCT02781584)
NCT ID: NCT02781584
Last Updated: 2022-03-16
Results Overview
Treatment-emergent AEs were defined as events that met 1 or both of the following criteria: * Any AEs with onset dates on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
220 participants
Primary outcome timeframe
Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase.
Results posted on
2022-03-16
Participant Flow
Participants were enrolled in study sites in the United States and New Zealand. The first participant was screened on 13 June 2016. The last study visit occurred on 17 December 2020.
Participant milestones
| Measure |
Cohort 1: SEL 18 mg (Non-cirrhotic)
Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
|
Cohort 2: FIR 20 mg (Non-cirrhotic)
Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
|
Cohort 3: CILO 30 mg (Non-cirrhotic)
Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
|
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 7: CILO 20 mg (Cirrhotic)
Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
|
Cohort 8: CILO 30 mg (Cirrhotic)
Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 10: FIR 20 mg + FENO 48 mg
Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 11: FIR 20 mg + FENO 145 mg
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
Participants received Vascepa® (VAS) 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-treatment Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
16
|
33
|
33
|
|
Pre-treatment Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
16
|
30
|
32
|
|
Pre-treatment Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
|
Treatment Phase
STARTED
|
10
|
10
|
10
|
20
|
20
|
20
|
10
|
10
|
13
|
15
|
16
|
30
|
32
|
|
Treatment Phase
COMPLETED
|
10
|
10
|
10
|
20
|
20
|
19
|
10
|
9
|
13
|
15
|
15
|
28
|
32
|
|
Treatment Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: SEL 18 mg (Non-cirrhotic)
Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
|
Cohort 2: FIR 20 mg (Non-cirrhotic)
Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
|
Cohort 3: CILO 30 mg (Non-cirrhotic)
Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
|
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 7: CILO 20 mg (Cirrhotic)
Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
|
Cohort 8: CILO 30 mg (Cirrhotic)
Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 10: FIR 20 mg + FENO 48 mg
Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 11: FIR 20 mg + FENO 145 mg
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
Participants received Vascepa® (VAS) 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-treatment Phase
Investigator's Discretion
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Pre-treatment Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Phase
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Treatment Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Cohort 1: SEL 18 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received SEL 18 mg tablet orally once daily for 12 weeks
|
Cohort 2: FIR 20 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received FIR 20 mg tablet orally once daily for 12 weeks
|
Cohort 3: CILO 30 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 7: CILO 20 mg (Cirrhotic)
n=10 Participants
Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
|
Cohort 8: CILO 30 mg (Cirrhotic)
n=10 Participants
Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
n=13 Participants
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 10: FIR 20 mg + FENO 48 mg
n=15 Participants
Participants received FENO 48 mg tablet orally for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 11: FIR 20 mg + FENO 145 mg
n=16 Participants
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
n=30 Participants
Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
n=32 Participants
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
57 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
53 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
56 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
48 years
STANDARD_DEVIATION 13.8 • n=21 Participants
|
55 years
STANDARD_DEVIATION 10.7 • n=8 Participants
|
60 years
STANDARD_DEVIATION 11.1 • n=8 Participants
|
60 years
STANDARD_DEVIATION 9.5 • n=24 Participants
|
56 years
STANDARD_DEVIATION 8.2 • n=42 Participants
|
59 years
STANDARD_DEVIATION 9.7 • n=42 Participants
|
52 years
STANDARD_DEVIATION 14.2 • n=42 Participants
|
56 years
STANDARD_DEVIATION 11.1 • n=42 Participants
|
52 years
STANDARD_DEVIATION 11.5 • n=36 Participants
|
55 years
STANDARD_DEVIATION 11.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
22 Participants
n=36 Participants
|
148 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
68 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
17 Participants
n=36 Participants
|
115 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
101 Participants
n=36 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
30 Participants
n=36 Participants
|
205 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
32 Participants
n=36 Participants
|
209 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase.Population: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug.
Treatment-emergent AEs were defined as events that met 1 or both of the following criteria: * Any AEs with onset dates on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug
Outcome measures
| Measure |
Cohort 1: SEL 18 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
|
Cohort 2: FIR 20 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
|
Cohort 3: CILO 30 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
|
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 7: CILO 20 mg (Cirrhotic)
n=10 Participants
Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
|
Cohort 8: CILO 30 mg (Cirrhotic)
n=10 Participants
Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
n=13 Participants
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 10: FIR 20 mg + FENO 48 mg
n=15 Participants
Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 11: FIR 20 mg + FENO 145 mg
n=16 Participants
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
n=30 Participants
Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
n=32 Participants
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
|
50 percentage of participants
|
60 percentage of participants
|
50 percentage of participants
|
25 percentage of participants
|
40 percentage of participants
|
50 percentage of participants
|
80 percentage of participants
|
70 percentage of participants
|
76.92 percentage of participants
|
86.67 percentage of participants
|
87.5 percentage of participants
|
40 percentage of participants
|
37.5 percentage of participants
|
PRIMARY outcome
Timeframe: Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase.Population: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug.
A treatment emergent serious adverse event (SAE) was defined as an event that, at any dose, results in the following: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * A congenital anomaly/birth defect * A medically important event or reaction
Outcome measures
| Measure |
Cohort 1: SEL 18 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
|
Cohort 2: FIR 20 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
|
Cohort 3: CILO 30 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
|
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 7: CILO 20 mg (Cirrhotic)
n=10 Participants
Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
|
Cohort 8: CILO 30 mg (Cirrhotic)
n=10 Participants
Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
n=13 Participants
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 10: FIR 20 mg + FENO 48 mg
n=15 Participants
Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 11: FIR 20 mg + FENO 145 mg
n=16 Participants
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
n=30 Participants
Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
n=32 Participants
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5 percentage of participants
|
5 percentage of participants
|
5 percentage of participants
|
10 percentage of participants
|
0 percentage of participants
|
7.69 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.33 percentage of participants
|
3.12 percentage of participants
|
PRIMARY outcome
Timeframe: Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase.Population: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug.
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days for subjects who permanently discontinued study drug. If baseline laboratory data were missing, then any abnormality of at least Grade 1 was considered treatment emergent. Graded laboratory abnormalities were defined using the grading scheme in the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 for Cohorts 1-9 and CTCAE Version 5.0 for Cohorts 10-13.
Outcome measures
| Measure |
Cohort 1: SEL 18 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
|
Cohort 2: FIR 20 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
|
Cohort 3: CILO 30 mg (Non-cirrhotic)
n=10 Participants
Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
|
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
n=20 Participants
Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 7: CILO 20 mg (Cirrhotic)
n=10 Participants
Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
|
Cohort 8: CILO 30 mg (Cirrhotic)
n=10 Participants
Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
n=13 Participants
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 10: FIR 20 mg + FENO 48 mg
n=15 Participants
Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 11: FIR 20 mg + FENO 145 mg
n=16 Participants
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
n=30 Participants
Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
n=32 Participants
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Grade 3 or Higher Laboratory Abnormalities
|
20 percentage of participants
|
20 percentage of participants
|
40 percentage of participants
|
10 percentage of participants
|
20 percentage of participants
|
10 percentage of participants
|
40 percentage of participants
|
30 percentage of participants
|
15.4 percentage of participants
|
6.7 percentage of participants
|
12.5 percentage of participants
|
6.7 percentage of participants
|
6.3 percentage of participants
|
Adverse Events
Cohort 1: SEL 18 mg (Non-cirrhotic)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: FIR 20 mg (Non-cirrhotic)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3: CILO 30 mg (Non-cirrhotic)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 7: CILO 20 mg (Cirrhotic)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 8: CILO 30 mg (Cirrhotic)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 10: FIR 20 mg + FENO 48 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 11: FIR 20 mg + FENO 145 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: SEL 18 mg (Non-cirrhotic)
n=10 participants at risk
Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
|
Cohort 2: FIR 20 mg (Non-cirrhotic)
n=10 participants at risk
Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
|
Cohort 3: CILO 30 mg (Non-cirrhotic)
n=10 participants at risk
Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
|
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
n=20 participants at risk
Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
n=20 participants at risk
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
n=20 participants at risk
Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 7: CILO 20 mg (Cirrhotic)
n=10 participants at risk
Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
|
Cohort 8: CILO 30 mg (Cirrhotic)
n=10 participants at risk
Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
n=13 participants at risk
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 10: FIR 20 mg + FENO 48 mg
n=15 participants at risk
Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 11: FIR 20 mg + FENO 145 mg
n=16 participants at risk
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
n=30 participants at risk
Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
n=32 participants at risk
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
Other adverse events
| Measure |
Cohort 1: SEL 18 mg (Non-cirrhotic)
n=10 participants at risk
Non-cirrhotic participants received selonsertib (SEL) 18 mg tablet orally once daily for 12 weeks
|
Cohort 2: FIR 20 mg (Non-cirrhotic)
n=10 participants at risk
Non-cirrhotic participants received firsocostat (FIR) 20 mg tablet orally once daily for 12 weeks
|
Cohort 3: CILO 30 mg (Non-cirrhotic)
n=10 participants at risk
Non-cirrhotic participants received cilofexor (CILO) 30 mg tablet once daily for 12 weeks
|
Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic)
n=20 participants at risk
Non-cirrhotic participants received SEL 18 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic)
n=20 participants at risk
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic)
n=20 participants at risk
Non-cirrhotic participants received CILO 30 mg tablet + FIR 20 mg tablet once daily for 12 weeks
|
Cohort 7: CILO 20 mg (Cirrhotic)
n=10 participants at risk
Participants with Child-Pugh-Turcotte Class A cirrhosis received FIR 20 mg tablet once daily for 12 weeks
|
Cohort 8: CILO 30 mg (Cirrhotic)
n=10 participants at risk
Participants with Child-Pugh-Turcotte Class A cirrhosis received CILO 30 mg tablet once daily for 12 weeks
|
Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic)
n=13 participants at risk
Non-cirrhotic participants received SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet once daily for 12 weeks
|
Cohort 10: FIR 20 mg + FENO 48 mg
n=15 participants at risk
Participants received FENO 48 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 48 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 11: FIR 20 mg + FENO 145 mg
n=16 participants at risk
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet + FENO 145 mg tablet orally once daily for 24 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 12: FIR 20 mg + CILO 30 mg + VAS 2g
n=30 participants at risk
Participants received VAS 2 g capsule orally twice daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + VAS 2 g capsule twice daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
Cohort 13: FIR 20 mg + CILO 30 mg + FENO 145 mg
n=32 participants at risk
Participants received FENO 145 mg tablet orally once daily for 2 weeks in the pretreatment phase, then FIR 20 mg tablet once daily + CILO 30 mg tablet once daily + FENO 145 mg tablet orally once daily for 6 weeks in the treatment phase. Participants with compensated cirrhosis due to NASH were accepted to participate in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
20.0%
2/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
15.4%
2/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
12.5%
2/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
23.1%
3/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
20.0%
3/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
15.0%
3/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
2/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
12.5%
2/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
9.4%
3/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
15.0%
3/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
15.4%
2/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
13.3%
2/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
General disorders
Chest pain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
General disorders
Facial pain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
15.4%
2/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
18.8%
3/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
20.0%
2/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
12.5%
2/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Furuncle
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
12.5%
2/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Localised infection
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
2/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
15.4%
2/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
33.3%
5/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
2/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Increased appetite
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
20.0%
3/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
12.5%
2/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
9.4%
3/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
23.1%
3/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
13.3%
2/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
2/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
12.5%
2/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
18.8%
3/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
20.0%
2/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
15.4%
2/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
12.5%
2/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
2/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
38.5%
5/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
25.0%
4/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.1%
1/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Psychiatric disorders
Mood swings
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Renal and urinary disorders
Renal atrophy
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
3.3%
1/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
12.5%
2/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
10.0%
1/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
20.0%
2/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
20.0%
2/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
5.0%
1/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.7%
1/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/20 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/10 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
7.7%
1/13 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/15 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
6.2%
1/16 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/30 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
0.00%
0/32 • Adverse Events: First dose date up to last dose (Cohorts 1-9: up to 12 weeks; Cohorts 10-11: up to 26 weeks; Cohorts 12-13: up to 8 weeks) plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. All-cause Mortality: Cohorts 1 through 6 and 9: Enrollment up to 12 weeks plus 30 days; Cohorts 7-8: Randomization up to 12 weeks plus 30 days; Cohorts 10-11: Randomization up to 26 weeks plus 30 days; Cohort 12-13: Randomization up to 8 weeks plus 30 days
Adverse Events: The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. All-cause Mortality: All Enrolled Analysis Set included all participants in Cohorts 1 through 6 and 9 who received a study subject identification number in the study after screening. The Randomized Analysis Set included all participants who were randomized into Cohorts 7, 8, and Cohorts 10-13.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met. * The results of the study in their entirely have been publicly disclosed by our with the consent of Gilead in an abstract, manuscript, presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER