Trial Outcomes & Findings for Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab (NCT NCT02330562)
NCT ID: NCT02330562
Last Updated: 2022-06-08
Results Overview
Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by the investigator, according to RANO 2010 criteria. Tumor response assessment was conducted every 2 cycles of study therapy. 95% confidence interval from exact binomial distribution (Clopper-Pearson method).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
121 participants
Primary outcome timeframe
From first dose to end of study treatment (up to approx. 48 weeks)
Results posted on
2022-06-08
Participant Flow
Participant milestones
| Measure |
Part 1 Cohort 1
Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 Cohort 2
Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 MTD + Dose Expansion Cohort
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 2
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 3
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 4
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 5
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
27
|
30
|
31
|
10
|
1
|
1
|
1
|
5
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
27
|
30
|
31
|
10
|
1
|
1
|
1
|
5
|
6
|
Reasons for withdrawal
| Measure |
Part 1 Cohort 1
Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 Cohort 2
Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 MTD + Dose Expansion Cohort
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 2
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 3
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 4
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 5
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
0
|
3
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Participant decision
|
1
|
0
|
4
|
1
|
5
|
2
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Disease progression
|
5
|
3
|
20
|
28
|
23
|
7
|
1
|
1
|
1
|
0
|
5
|
|
Overall Study
Other reasons
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab
Baseline characteristics by cohort
| Measure |
Part 1 Cohort 1
n=6 Participants
Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 Cohort 2
n=3 Participants
Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 MTD + Dose Expansion Cohort
n=27 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=30 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=31 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
n=10 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1
n=1 Participants
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 2
n=1 Participants
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 3
n=1 Participants
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 4
n=5 Participants
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 5
n=6 Participants
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
97 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
66 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 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
|
8 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
113 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 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
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
106 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=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
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 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
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From first dose to end of study treatment (up to approx. 48 weeks)Population: All treated participants in Part 2 Cohort
Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by the investigator, according to RANO 2010 criteria. Tumor response assessment was conducted every 2 cycles of study therapy. 95% confidence interval from exact binomial distribution (Clopper-Pearson method).
Outcome measures
| Measure |
Part 2 Cohort
n=30 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Radiographic Objective Response Rate (ORR) - Part 2 Cohort
|
3.3 Percent of participants
Interval 0.1 to 17.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to death, assessed up approx. 42 weeksPopulation: All treated participants in Part 3
OS is defined as time from the date of the first dose of study drug to date of death due to any cause. Participants who are alive will be censored at the last follow up visit
Outcome measures
| Measure |
Part 2 Cohort
n=31 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
n=10 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) - Part 3 Cohorts
|
8.3 Months
Interval 4.8 to 11.3
|
7.5 Months
Interval 3.5 to 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 28 days following last dose (up to approx. 72 weeks for Part 1, approx. 52 weeks for Part 2, approx. 46 weeks for Part 3, and approx. 37 weeks for Part 4)Population: All treated participants
Number of subjects experiencing at least 1 Treatment-Emergent Adverse Event (TEAE) within the timeframe specified. For Part 4, data are presented separately for Cycle 1 (when Marizomib was enterally-administered) and for Cycles 2 and subsequent cycles (when Marizomib was administered IV)
Outcome measures
| Measure |
Part 2 Cohort
n=6 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
n=3 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
n=27 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=30 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=31 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
n=10 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
n=1 Participants
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
n=1 Participants
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
n=1 Participants
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
n=5 Participants
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
n=6 Participants
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
n=11 Participants
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events
|
6 Participants
|
3 Participants
|
27 Participants
|
30 Participants
|
31 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From first dose to 28 days following last dose (up to approx. 72 weeks for Part 1, approx. 52 weeks for Part 2, approx. 46 weeks for Part 3, and approx. 37 weeks for Part 4)Population: All treated participants
Number of subjects experiencing at least 1 Serious Adverse Event (SAE) within the timeframe specified. For Part 4, data are presented separately for Cycle 1 (when Marizomib was enterally-administered) and for Cycles 2 and subsequent cycles (when Marizomib was administered IV)
Outcome measures
| Measure |
Part 2 Cohort
n=6 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
n=3 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
n=27 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=30 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=31 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
n=10 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
n=1 Participants
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
n=1 Participants
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
n=1 Participants
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
n=5 Participants
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
n=6 Participants
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
n=11 Participants
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
12 Participants
|
10 Participants
|
14 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From first dose to 28 days first dose (during Cycle 1 of study treatment)Population: All treated participants in Part 1 and Part 4
Number of subjects experiencing at least 1 DLT event within the timeframe specified. DLT is defined as the occurrence of any of the following AEs related to one of the drugs or the combination observed during Cycle 1, using NCI-CTCAE (v 4.03): * ≥ Grade 3 thrombocytopenia or Grade 2 thrombocytopenia with bleeding. * Grade 4 neutropenia or anemia lasting for more than 4 days. * Febrile neutropenia. * Any ≥ Grade 2 neurological event lasting more than 4 days. * Grade 3 or 4 non-hematologic toxicity (excluding alopecia), lasting for more than 4 days despite adequate supportive therapy or preventing the next scheduled dose from being administered within 4 days of scheduled day; for ≥ Grade 3 fatigue to be considered a DLT, it must be present for more than 7 days. For Part 4, data are presented separately for Cycle 1 (when Marizomib was enterally-administered) and for Cycles 2 and subsequent cycles (when Marizomib was administered IV). DLT was assessed only for Part 1 and Part 4 cohorts.
Outcome measures
| Measure |
Part 2 Cohort
n=6 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
n=3 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
n=27 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=1 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=1 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
n=1 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
n=5 Participants
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
n=6 Participants
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 28 days following last dose (up to approx. 46 weeks)Population: All treated participants in Part 3
Number of subjects experiencing at least 1 DLAE within the timeframe specified. DLAEs are defined as Marizomib-related AEs observed which are: * related to disturbances in the cerebellum (ie, ataxia, dizziness, dysarthria, fall, gait disturbances) plus hallucinations of any grade * any other AEs of Grade ≥ 2. DLAEs were assessed only for Part 3 cohorts.
Outcome measures
| Measure |
Part 2 Cohort
n=31 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
n=10 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Adverse Events (DLAEs)
|
31 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to end of study treatment (up to approx. 68 weeks for Part 1, and approx. 42 weeks for Part 3)Population: All treated participants with available measurements
Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by the investigator, according to RANO 2010 criteria. Tumor response assessment was conducted every 2 cycles of study therapy. 95% confidence interval from exact binomial distribution (Clopper-Pearson method). Radiographic ORR was assessed for Part 1 and Part 3 cohorts
Outcome measures
| Measure |
Part 2 Cohort
n=6 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
n=3 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
n=25 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=29 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=10 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Radiographic Objective Response Rate (ORR)
|
50.0 Percent of participants
Insufficient number of events
|
33.3 Percent of participants
Insufficient number of events
|
48.0 Percent of participants
Interval 27.8 to 68.7
|
24.1 Percent of participants
Interval 10.3 to 43.5
|
20.0 Percent of participants
Interval 2.5 to 55.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to disease progression or death, assessed up to approx. 68 weeks for Part 1, approx. 48 weeks for Part 2, approx. 42 weeks for Part 3, and approx. 33 weeks for Part 4Population: All treated participants
PFS is defined as the time between start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurs first. Disease progression will be determined using RANO 2010 criteria as assessed by the investigator. PFS was determined using Kaplan-Meier product-limit estimates.
Outcome measures
| Measure |
Part 2 Cohort
n=6 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
n=3 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
n=27 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=30 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=31 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
n=10 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
n=1 Participants
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
n=1 Participants
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
n=1 Participants
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
n=5 Participants
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
n=6 Participants
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
7.3 Months
Insufficient number of events
|
3.7 Months
Insufficient number of events
|
3.9 Months
Interval 1.9 to 5.5
|
1.8 Months
Interval 1.5 to 1.9
|
3.5 Months
Interval 2.6 to 3.6
|
2.1 Months
Interval 1.5 to 5.3
|
5.1 Months
Insufficient number of events
|
2.3 Months
Insufficient number of events
|
7.4 Months
Insufficient number of events
|
NA Months
Interval 1.8 to
Insufficient number of events
|
3.8 Months
Interval 1.9 to
Insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: From first dose to death, assessed up to approx. 68 weeks for Part 1, approx. 48 weeks for Part 2, and approx. 33 weeks for Part 4Population: All treated participants
OS is defined as time from the date of the first dose of study drug to date of death due to any cause. Participants who are alive will be censored at the last follow up visit
Outcome measures
| Measure |
Part 2 Cohort
n=6 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 2
n=3 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 1 MTD + Dose Expansion Cohort
n=27 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=30 Participants
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=1 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
n=1 Participants
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1 - Cycle 1
n=1 Participants
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 2 - Cycle 1
n=5 Participants
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 3 - Cycle 1
n=6 Participants
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 4 - Cycle 1
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 Cohort 5 - Cycle 1
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 + Bevacizumab 10 mg/Kg on Days 1 and 15
|
Part 4 All Cohorts - Cycles 2 and Subsequent
Marizomib at different dosage IV-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
10.4 Months
Insufficient number of events
|
6.3 Months
Insufficient number of events
|
10.4 Months
Interval 6.0 to 14.1
|
11.4 Months
Interval 5.5 to 13.0
|
8.3 Months
Insufficient number of events
|
NA Months
Insufficient number of events
|
14.2 Months
Insufficient number of events
|
NA Months
Interval 7.7 to
Insufficient number of events
|
8.7 Months
Interval 1.9 to
Insufficient number of events
|
—
|
—
|
—
|
Adverse Events
Part 1 Cohort 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 5 deaths
Part 1 Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Part 1 MTD + Dose Expansion Cohort
Serious events: 12 serious events
Other events: 26 other events
Deaths: 21 deaths
Part 2 Cohort
Serious events: 10 serious events
Other events: 30 other events
Deaths: 24 deaths
Part 3 Cohort 1
Serious events: 14 serious events
Other events: 31 other events
Deaths: 25 deaths
Part 3 Cohort 2
Serious events: 5 serious events
Other events: 10 other events
Deaths: 9 deaths
Part 4 Cohort 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Part 4 Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 4 Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Part 4 Cohort 4
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Part 4 Cohort 5
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Part 1 Cohort 1
n=6 participants at risk
Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 Cohort 2
n=3 participants at risk
Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 MTD + Dose Expansion Cohort
n=27 participants at risk
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=30 participants at risk
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=31 participants at risk
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
n=10 participants at risk
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1
n=1 participants at risk
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 2
n=1 participants at risk
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 3
n=1 participants at risk
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 4
n=5 participants at risk
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 5
n=6 participants at risk
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Asthenia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Disease progression
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Facial pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Fatigue
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Convulsion
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Delusion
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Hallucination
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
Other adverse events
| Measure |
Part 1 Cohort 1
n=6 participants at risk
Marizomib 0.55 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 Cohort 2
n=3 participants at risk
Marizomib 0.7 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle
|
Part 1 MTD + Dose Expansion Cohort
n=27 participants at risk
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle.
MTD = Maximum Tolerated Dose
|
Part 2 Cohort
n=30 participants at risk
Marizomib 0.8 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
|
Part 3 Cohort 1
n=31 participants at risk
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on presence of dose-limiting adverse events, participants did not escalate Marizomib to a dose of 1.0 mg/m2
|
Part 3 Cohort 2
n=10 participants at risk
Marizomib 0.8 mg/m2 on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. Based on lack of dose-limiting adverse events for at least 1 cycle, participants were allowed to escalate Marizomib to a dose of 1.0 mg/m2
|
Part 4 Cohort 1
n=1 participants at risk
Marizomib 0.075 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 2
n=1 participants at risk
Marizomib 0.225 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 3
n=1 participants at risk
Marizomib 0.675 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 4
n=5 participants at risk
Marizomib 1.0 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
Part 4 Cohort 5
n=6 participants at risk
Marizomib 1.35 mg/m2 enterally-administered on Days 1,8, and 15 of each 28-day cycle + Bevacizumab 10 mg/Kg on Days 1 and 15 of each 28-day cycle. From Cycle 2, Marizomib was administered at a dose of 0.8 mg/m2 IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
22.2%
6/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
6/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
12.9%
4/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
2/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Cataract
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
4/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Eye disorder
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
2/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
32.3%
10/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
25.9%
7/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
10/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
19.4%
6/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
30.0%
3/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
29.6%
8/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
23.3%
7/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
32.3%
10/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
60.0%
3/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Faecal incontinence
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
2/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
63.0%
17/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
36.7%
11/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
41.9%
13/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
60.0%
6/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
5/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
83.3%
5/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
59.3%
16/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
10/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
51.6%
16/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
60.0%
6/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
5/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
6/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Asthenia
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.1%
5/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Catheter site bruise
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Chills
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Extravasation
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Fatigue
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
2/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
74.1%
20/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
20/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
77.4%
24/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
90.0%
9/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
60.0%
3/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
83.3%
5/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
5/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
48.4%
15/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
50.0%
5/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
12.9%
4/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Infusion site erythema
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Infusion site pain
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
13.3%
4/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Infusion site reaction
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Injection site pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Malaise
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Oedema
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
5/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
General disorders
Pyrexia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Immune system disorders
Seasonal allergy
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Herpes zoster
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.1%
5/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Hemianopia homonymous
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
25.9%
7/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
13.3%
4/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
38.7%
12/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
30.0%
3/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
5/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
2/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
18.5%
5/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
23.3%
7/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
19.4%
6/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
2/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
Weight decreased
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Gout
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
22.2%
6/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
26.7%
8/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
22.6%
7/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
2/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
2/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
13.3%
4/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
19.4%
6/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
6/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.1%
5/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
2/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
18.5%
5/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
26.7%
8/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
32.3%
10/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
6/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
22.6%
7/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
18.5%
5/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
5/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
32.3%
10/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
30.0%
3/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
23.3%
7/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
19.4%
6/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
30.0%
3/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
25.9%
7/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
23.3%
7/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
35.5%
11/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
13.3%
4/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Convulsion
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
13.3%
4/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
12.9%
4/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
30.0%
3/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Hemiparesis
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
13.3%
4/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
30.0%
3/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Disturbance in attention
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
29.6%
8/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
5/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
38.7%
12/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
4/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
18.5%
5/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
23.3%
7/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
29.0%
9/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
4/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Haemorrhage intracranial
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
3/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
44.4%
12/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
46.7%
14/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
41.9%
13/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
50.0%
5/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
83.3%
5/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
25.9%
7/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
22.6%
7/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Partial seizures
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
14.8%
4/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Quadranopia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Sinus headache
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.1%
5/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
4/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Anxiety
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
25.9%
7/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
23.3%
7/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
51.6%
16/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
70.0%
7/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
2/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Depression
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
44.4%
12/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
40.0%
12/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
61.3%
19/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
60.0%
6/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
4/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
43.3%
13/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
29.0%
9/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Personality change
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
12.9%
4/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.1%
5/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
9.7%
3/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
37.0%
10/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
29.0%
9/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
29.6%
8/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
2/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
18.5%
5/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
7.4%
2/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.2%
1/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
11.1%
3/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.7%
1/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
1/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.7%
2/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Hypertension
|
50.0%
3/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
66.7%
2/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
37.0%
10/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
10.0%
3/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
22.6%
7/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
30.0%
3/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
100.0%
1/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
20.0%
1/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
2/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
3.3%
1/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
33.3%
1/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Phlebitis
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
6.5%
2/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
|
Vascular disorders
Vascular pain
|
16.7%
1/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/3 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/27 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/30 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/31 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/10 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/1 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/5 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
0.00%
0/6 • All-cause mortality: from randomization to study completion (up to approximately 73 months) SAEs and Other Adverse Events: from first dose to 28 days following last dose (up to approximately 72 weeks)
All treated participants
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER