Trial Outcomes & Findings for A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) (NCT NCT03281369)
NCT ID: NCT03281369
Last Updated: 2026-08-03
Results Overview
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1, as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
219 participants
Primary outcome timeframe
From randomization up to approximately 84.2 months
Results posted on
2026-08-03
Participant Flow
A total of 219 participants with metastatic gastric or esophageal cancer took part in the study from 13 Oct 2017 to 09 Oct 2025. The study enrolled participants with gastric cancer (GC) in 2 cohorts: Cohort 1: received no prior systemic therapy for GC \& Cohort 2: received 1 prior line of systemic therapy for GC and participants with esophageal cancer in 1 cohort (received no prior systemic treatment).
Eligible participants were assigned to one of several treatment arms in Stage 1. Cohort 2 participants with disease progression (PD), loss of clinical benefit, or unacceptable toxicity in Stage 1 were eligible for a different treatment combination in Stage 2. Results include only those cohorts that enrolled participants. Planned cohorts that did not enroll participants or were never opened are not presented.
Participant milestones
| Measure |
Stage 1: Atezolizumab + Cisplatin + 5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 milligrams (mg), intravenous (IV) infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 milligrams per square meter (mg/m\^2) for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-fluorouracil (5-FU), 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, by mouth (PO), once a day (QD) on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the long-term survival follow-up (LTSFU).
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the first-line (1L) setting received ramucirumab, 8 milligrams per kilogram (mg/kg), IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, subcutaneous (SC) injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
65
|
5
|
16
|
15
|
15
|
16
|
24
|
63
|
0
|
|
Stage 1
Safety-evaluable (SE) Population
|
65
|
5
|
12
|
13
|
13
|
14
|
23
|
62
|
0
|
|
Stage 1
Efficacy Population
|
65
|
5
|
12
|
13
|
13
|
14
|
23
|
62
|
0
|
|
Stage 1
COMPLETED
|
61
|
4
|
11
|
13
|
12
|
11
|
23
|
57
|
0
|
|
Stage 1
NOT COMPLETED
|
4
|
1
|
5
|
2
|
3
|
5
|
1
|
6
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
|
Stage 2
SE Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
|
Long-term Survival Follow Up (LTSFU)
NOT COMPLETED
|
61
|
4
|
11
|
13
|
12
|
11
|
8
|
57
|
15
|
|
Stage 2
Efficacy Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long-term Survival Follow Up (LTSFU)
STARTED
|
61
|
4
|
11
|
13
|
12
|
11
|
8
|
57
|
15
|
|
Long-term Survival Follow Up (LTSFU)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Stage 1: Atezolizumab + Cisplatin + 5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 milligrams (mg), intravenous (IV) infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 milligrams per square meter (mg/m\^2) for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-fluorouracil (5-FU), 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, by mouth (PO), once a day (QD) on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the long-term survival follow-up (LTSFU).
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the first-line (1L) setting received ramucirumab, 8 milligrams per kilogram (mg/kg), IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, subcutaneous (SC) injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
Progression of Disease
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Death
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
3
|
0
|
|
Stage 1
Withdrawal by Subject
|
1
|
0
|
3
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Stage 1
Reason Not Specified
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 1
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Stage 1
Study Terminated by Sponsor
|
2
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Stage 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Long-term Survival Follow Up (LTSFU)
Study Terminated by Sponsor
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
4
|
|
Long-term Survival Follow Up (LTSFU)
Death
|
55
|
3
|
11
|
13
|
10
|
10
|
7
|
42
|
11
|
|
Long-term Survival Follow Up (LTSFU)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Long-term Survival Follow Up (LTSFU)
Symptomatic Deterioration
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Long-term Survival Follow Up (LTSFU)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
0
|
Baseline Characteristics
Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
Baseline characteristics by cohort
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=5 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=16 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=15 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=15 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=16 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=24 Participants
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=65 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=63 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
n=15 Participants
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Stage 1: Adults (18-64 years)
|
2 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
9 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
11 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
11 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
14 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
21 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
38 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
31 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
—
|
137 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
|
Age, Customized
Stage 1: From 65-84 years
|
3 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
7 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
4 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
4 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
2 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
2 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
27 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
32 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
—
|
81 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
|
Age, Customized
Stage 1: 85 years and over
|
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
1 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
0 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
0 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
—
|
1 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
|
Age, Customized
Stage 2: Adults (18-64 years)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11 Participants
n=14 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
11 Participants
n=14 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
|
Age, Customized
Stage 2: From 65-84 years
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=14 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
3 Participants
n=14 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
|
Age, Customized
Stage 2: 85 years and over
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=14 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
0 Participants
n=14 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen, and for whom age data were available for analysis.
|
|
Sex: Female, Male
Stage 1 · Female
|
1 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
3 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
6 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
28 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Sex: Female, Male
Stage 1 · Male
|
4 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
12 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
12 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
13 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
14 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
24 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
59 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
53 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
191 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Sex: Female, Male
Stage 2 · Female
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Sex: Female, Male
Stage 2 · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
15 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Ethnicity (NIH/OMB)
Stage 1 · Hispanic or Latino
|
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
5 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Ethnicity (NIH/OMB)
Stage 1 · Not Hispanic or Latino
|
5 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
16 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
15 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
11 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
16 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
22 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
61 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
62 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
208 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Ethnicity (NIH/OMB)
Stage 1 · Unknown or Not Reported
|
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
6 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
14 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · American Indian or Alaska Native
|
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
0 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · Asian
|
3 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
8 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
7 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
11 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
18 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
37 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
43 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
137 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
1 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · Black or African American
|
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
1 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · White
|
2 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
6 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
7 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
6 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
6 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
26 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
18 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
75 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · More than one race
|
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
0 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · Unknown or Not Reported
|
0 Participants
n=5 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=16 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=24 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=65 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=63 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
5 Participants
n=219 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
12 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
3 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · More than one race
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced PD or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
PRIMARY outcome
Timeframe: From randomization up to approximately 84.2 monthsPopulation: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen.
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1, as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=5 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=12 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=14 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=23 Participants
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=65 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=62 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to RECIST v1.1
|
40.0 percentage of participants
Interval 5.27 to 85.34
|
16.7 percentage of participants
Interval 2.09 to 48.41
|
0 percentage of participants
Interval 0.0 to 24.71
|
15.4 percentage of participants
Interval 1.92 to 45.45
|
21.4 percentage of participants
Interval 4.66 to 50.8
|
47.8 percentage of participants
Interval 26.82 to 69.41
|
53.8 percentage of participants
Interval 41.03 to 66.3
|
67.7 percentage of participants
Interval 54.66 to 79.06
|
—
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of PD or death (up to approximately 84.2 months)Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen.
PFS was defined as the time from randomization to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate PFS.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=5 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=12 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=14 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=23 Participants
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=65 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=62 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Progression Free Survival (PFS) After Randomization, as Determined by Investigator According to RECIST v1.1
|
14.93 months
Interval 10.64 to
Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
|
6.06 months
Interval 3.68 to 8.77
|
1.84 months
Interval 1.48 to 2.1
|
1.97 months
Interval 1.71 to 7.92
|
1.95 months
Interval 1.64 to 4.93
|
5.98 months
Interval 2.69 to 8.11
|
7.03 months
Interval 5.55 to 8.28
|
6.90 months
Interval 5.95 to 9.89
|
—
|
SECONDARY outcome
Timeframe: From randomization to death (up to approximately 84.2 months)Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen.
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M methodology was used to estimate the median OS.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=5 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=12 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=14 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=23 Participants
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=65 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=62 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Overall Survival (OS) After Randomization
|
16.99 months
Interval 14.65 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
8.33 months
Interval 6.37 to 10.94
|
7.00 months
Interval 5.26 to 8.87
|
10.64 months
Interval 3.71 to 39.06
|
8.57 months
Interval 4.27 to 28.12
|
10.09 months
Interval 7.59 to 23.2
|
12.98 months
Interval 11.17 to 15.7
|
16.56 months
Interval 12.22 to 21.03
|
—
|
SECONDARY outcome
Timeframe: At Months 6 and 12Population: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The K-M approach was used to estimate the percentage of participants who were event-free for OS at Month 6 and Month 12. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=4 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=9 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=7 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=6 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=7 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=17 Participants
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=56 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=54 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: OS at Month 6 and Month 12
Month 6
|
100.00 percentage of participants
Interval 100.0 to 100.0
|
75.00 percentage of participants
Interval 50.5 to 99.5
|
53.85 percentage of participants
Interval 26.75 to 80.95
|
51.28 percentage of participants
Interval 23.1 to 79.47
|
56.25 percentage of participants
Interval 29.8 to 82.7
|
78.02 percentage of participants
Interval 60.98 to 95.06
|
87.52 percentage of participants
Interval 79.43 to 95.61
|
88.65 percentage of participants
Interval 80.73 to 96.57
|
—
|
|
Stage 1: OS at Month 6 and Month 12
Month 12
|
100.00 percentage of participants
Interval 100.0 to 100.0
|
25.00 percentage of participants
Interval 0.5 to 49.5
|
23.08 percentage of participants
Interval 0.17 to 45.98
|
42.74 percentage of participants
Interval 14.71 to 70.76
|
40.18 percentage of participants
Interval 13.51 to 66.85
|
36.71 percentage of participants
Interval 16.54 to 56.89
|
57.83 percentage of participants
Interval 45.73 to 69.92
|
65.36 percentage of participants
Interval 53.36 to 77.36
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 84.2 monthsPopulation: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed is the number of participants with OR (CR or PR).
DOR was defined as time from first occurrence of a documented OR until the time of documented PD as determined by investigator assessment using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. K-M method was used to estimate DOR.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=2 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=2 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=2 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=3 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=11 Participants
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=35 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=42 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST v1.1
|
NA months
Median and 95% CI were not estimable due to insufficient number of participants with events.
|
3.32 months
Interval 2.89 to 3.75
|
—
|
NA months
Interval 58.84 to
Median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
|
14.46 months
Interval 3.55 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
5.91 months
Interval 2.83 to 14.06
|
6.90 months
Interval 5.32 to 8.77
|
7.16 months
Interval 4.4 to 15.31
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 84.2 monthsPopulation: Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen.
DC was defined as stable disease (SD) for ≥16 weeks for GC cohort or ≥ 12 weeks for esophageal cancer cohort, or CR/PR, as determined by investigator per RECIST v1.1. Disease control rate (DCR) was defined as percentage of participants with DC. CR was defined as disappearance of all target \& non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in SOD of target lesions, taking as reference baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least 20% increase in SOD of target lesions, taking as reference smallest sum on study including baseline (nadir). Additionally, the sum must also demonstrate absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=5 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=12 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=14 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=23 Participants
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=65 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=62 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST v1.1
|
80.0 percentage of participants
Interval 28.36 to 99.49
|
66.7 percentage of participants
Interval 34.89 to 90.08
|
0 percentage of participants
Interval 0.0 to 24.71
|
23.1 percentage of participants
Interval 5.04 to 53.81
|
21.4 percentage of participants
Interval 4.66 to 50.8
|
56.5 percentage of participants
Interval 34.49 to 76.81
|
78.5 percentage of participants
Interval 66.51 to 87.69
|
83.9 percentage of participants
Interval 72.33 to 91.98
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 monthsPopulation: Safety-evaluable (SE) population included all randomized participants who received any amount of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=5 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=12 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=13 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=14 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=23 Participants
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=65 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=62 Participants
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
n=14 Participants
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stages 1 and 2: Percentage of Participants With Adverse Events (AEs)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes (min) post-dose (infusion=60 min) on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16, 20, 24, & 28; Stage 1 treatment discontinuation (TD) (up to approximately 82.7 months)Population: Atezolizumab pharmacokinetic (PK)-evaluable population included all randomized participants who received at least one dose of atezolizumab. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
1 cycle = 21 days for the all three reported arms: Stage 1 Cohort 2: Atezolizumab + PEGPH20, Stage 1: Atezolizumab + Cisplatin + 5-FU" cohorts and Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU" cohort. The protocol pre-specified that PK assessments could be conducted only for treatment combinations selected by the sponsor for further development. As the sponsor decided not to continue further development of the mFOLFOX6 + atezolizumab + cobimetinib, atezolizumab + linagliptin, and atezolizumab + BL-8040 combinations, PK data were not reported for these cohorts.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=13 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=39 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=44 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 1
|
NA micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation NA
Geometric Mean (GM) and Geometric Coefficient of Variation were not estimable as the values were below the level of quantification.
|
NA micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation NA
GM and Geometric Coefficient of Variation were not estimable as the values were below the level of quantification.
|
NA micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation NA
GM and Geometric Coefficient of Variation were not estimable as the values were below the level of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
30 min post-dose on Day 1 of Cycle 1
|
362 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 39.2
|
375 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 21.6
|
379 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 22.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 2
|
64.4 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 28.0
|
70.9 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 48.8
|
60.8 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 43.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 3
|
95.6 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 37.2
|
113 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 54.3
|
87.3 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 77.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 4
|
117 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable for 1 participant.
|
137 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 47.6
|
108 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 56.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 8
|
—
|
216 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 37.1
|
185 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 44.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 12
|
—
|
204 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 29.1
|
159 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 46.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 16
|
—
|
289 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 29.2
|
206 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 34.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 20
|
—
|
—
|
273 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 24
|
—
|
—
|
239 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 35.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Pre-dose on Day 1 of Cycle 28
|
—
|
—
|
209 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable for 1 participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Atezolizumab
Stage 1 TD
|
93.7 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 58.5
|
195 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 55.9
|
89.8 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 130.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 30 min post-dose on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16, 20, 24, & 28 (1 Cycle=28 days); Stage 1 TD (up to approximately 46.7 months)Population: Tiragolumab PK-evaluable population included all randomized participants who received at least one dose of tiragolumab. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=43 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 1
|
NA μg/mL
Geometric Coefficient of Variation NA
GM and Geometric Coefficient of Variation were not estimable because the values were below the level of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Stage 1 TD
|
39.8 μg/mL
Geometric Coefficient of Variation 166.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
30 min post-dose on Day 1 of Cycle 1
|
223 μg/mL
Geometric Coefficient of Variation 20.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 2
|
31.4 μg/mL
Geometric Coefficient of Variation 45.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 3
|
43.3 μg/mL
Geometric Coefficient of Variation 85.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 4
|
50.5 μg/mL
Geometric Coefficient of Variation 62.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 8
|
83.4 μg/mL
Geometric Coefficient of Variation 39.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 12
|
76.1 μg/mL
Geometric Coefficient of Variation 58.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 16
|
87.6 μg/mL
Geometric Coefficient of Variation 30.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 20
|
102 μg/mL
Geometric Coefficient of Variation 15.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 24
|
97.8 μg/mL
Geometric Coefficient of Variation 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Serum Concentration of Tiragolumab
Pre-dose on Day 1 of Cycle 28
|
90.0 μg/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not estimable for 1 participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: Day 1 of Cycles 1, 2, 3, 4 & Days 8, 15 of Cycle 1; 5 minutes & 1-3 hours post-dose: Day 1 Cycle 1; 5 min post-dose: Day 1 Cycle 2; Stage 1: TD (up to approx 3.3 months) & Day 120 post last dose of atezo (up to approx 6.8 months)Population: PEGPH20 PK-evaluable population included all randomized participants who received at least one dose of PEGPH20. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
1 Cycle=21 days
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=12 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Plasma Concentration of PEGPH20
5 min post-dose on Day 1 of Cycle 2
|
56.3 μg/mL
Geometric Coefficient of Variation 42.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
Pre-dose on Day 1 of Cycle 1
|
NA μg/mL
Geometric Coefficient of Variation NA
GM and geometric coefficient of variation were not estimable because the values were below the level of detection.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
5 min post-dose on Day 1 of Cycle 1
|
31.4 μg/mL
Geometric Coefficient of Variation 1290.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
1-3 h post-dose on Day 1 of Cycle 1
|
25.8 μg/mL
Geometric Coefficient of Variation 1086.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
Pre-dose on Day 8 of Cycle 1
|
0.529 μg/mL
Geometric Coefficient of Variation NA
As the number of evaluable samples available for analysis was less than 3, the geometric coefficient of variation was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
Pre-dose on Day 15 of Cycle 1
|
0.485 μg/mL
Geometric Coefficient of Variation NA
As the number of evaluable samples available for analysis was less than 3, the geometric coefficient of variation was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
Pre-dose on Day 1 of Cycle 2
|
0.647 μg/mL
Geometric Coefficient of Variation NA
As the number of evaluable samples available for analysis was less than 3, the geometric coefficient of variation was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
Pre-dose on Day 1 of Cycle 3
|
1.92 μg/mL
Geometric Coefficient of Variation 1992.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
Pre-dose on Day 1 of Cycle 4
|
10.2 μg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable for 1 participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
Stage 1 TD
|
2.12 μg/mL
Geometric Coefficient of Variation 1276.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Plasma Concentration of PEGPH20
Stage 1 Day 120 post last dose
|
0.0375 μg/mL
Geometric Coefficient of Variation NA
As the number of evaluable samples available for analysis was less than 3, the geometric coefficient of variation was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 82.7 monthsPopulation: SE population included all randomized participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis.
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here. The protocol pre-specified that ADA assessments could be conducted only for treatment combinations selected by the sponsor for further development. As the sponsor decided not to continue further development of the mFOLFOX6 + atezolizumab + cobimetinib, atezolizumab + linagliptin, and atezolizumab + BL-8040 combinations, ADA data were not reported for these cohorts.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=10 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=39 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=43 Participants
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Atezolizumab
|
3 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 46.7 monthsPopulation: SE population included all randomized participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis.
Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=43 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Treatment-emergent ADAs to Tiragolumab
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3.3 monthsPopulation: SE population included all randomized participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis.
Participants who received PEGPH20 were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following PEGPH20 exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
Outcome measures
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=10 Participants
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Treatment-emergent ADAs to PEGPH20
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 12 deaths
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Serious events: 1 serious events
Other events: 13 other events
Deaths: 13 deaths
Stage 1 Cohort 2: Atezolizumab + BL-8040
Serious events: 5 serious events
Other events: 13 other events
Deaths: 11 deaths
Stage 1 Cohort 2: Atezolizumab + Linagliptin
Serious events: 4 serious events
Other events: 14 other events
Deaths: 13 deaths
Stage 1: Cisplatin + 5-FU (Control)
Serious events: 11 serious events
Other events: 23 other events
Deaths: 8 deaths
Stage 1: Atezolizumab + Cisplatin + 5-FU
Serious events: 34 serious events
Other events: 65 other events
Deaths: 56 deaths
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
Serious events: 38 serious events
Other events: 62 other events
Deaths: 45 deaths
Stage 2: Atezolizumab + Tiragolumab
Serious events: 7 serious events
Other events: 14 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=5 participants at risk
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=12 participants at risk
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=13 participants at risk
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=13 participants at risk
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=14 participants at risk
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=23 participants at risk
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=65 participants at risk
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=62 participants at risk
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
n=14 participants at risk
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Cor pulmonale acute
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Endocrine disorders
Primary adrenal insufficiency
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.1%
5/62 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Palatal ulcer
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Chest pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Chills
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Death
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Device related thrombosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
General physical health deterioration
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Malaise
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Sudden death
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Device related infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Recurrent pyogenic cholangitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Septic shock
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Wound infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Product Issues
Device malfunction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
20.0%
1/5 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Product Issues
Device occlusion
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Surgical and medical procedures
Euthanasia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
Other adverse events
| Measure |
Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib
n=5 participants at risk
Participants with metastatic GC who did not receive prior chemotherapy, received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle, oxaliplatin, 100 mg/m\^2 for 4 cycles, concurrently with leucovorin, 100 mg/m\^2, IV infusion on Days 1 and 15 of each cycle, 5-FU, 2400 mg/m\^2, IV infusion on Days 1 and 2 and on Days 15 and 16 of each cycle and cobimetinib, 40 mg or 60 mg, PO, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (cycle length=28 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)
n=12 participants at risk
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received ramucirumab, 8 mg/kg, IV infusion on Days 1 and 15 of each cycle and paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD per RECIST v1.1 (cycle length=28 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + PEGPH20
n=13 participants at risk
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received PEGPH20, 3 micrograms per kilogram (μg/kg), IV infusion on Days 1, 8 and 15 of each cycle, followed by atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + BL-8040
n=13 participants at risk
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle (cycle length=21 days) and BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of Cycle 1 (cycle length=5 days) and Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle from Cycle 2 onwards (cycle length=21 days) until loss of clinical benefit or unacceptable toxicity. After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1 Cohort 2: Atezolizumab + Linagliptin
n=14 participants at risk
Participants with metastatic GC who progressed after receiving a platinum-containing or fluoropyrimidine-containing chemotherapy regimen in the 1L setting received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and linagliptin, 5 mg, PO, QD on Days 1-21 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants entered the LTSFU.
|
Stage 1: Cisplatin + 5-FU (Control)
n=23 participants at risk
Participants with esophageal cancer who had not received prior systemic treatment received cisplatin, 80 mg/m\^2, IV infusion on Day 1 for the first six cycles and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity or PD per RECIST v1.1 (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab + Cisplatin + 5-FU
n=65 participants at risk
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Days 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 1: Atezolizumab +Tiragolumab + Cisplatin +5-FU
n=62 participants at risk
Participants with esophageal cancer who had not received prior systemic treatment received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle, tiragolumab, 600 mg IV on Day 1 of each cycle, along with cisplatin, 80 mg/m\^2, IV infusion on Day 1 of each cycle (capped after 6 doses), and 5-FU, 800 mg/m\^2/24 hours, IV (continuous) on Day 1-5 of each cycle until loss of clinical benefit or unacceptable toxicity (cycle length=21 days). After Stage 1, participants who did not enter Stage 2 entered the LTSFU.
|
Stage 2: Atezolizumab + Tiragolumab
n=14 participants at risk
Participants with esophageal cancer who experienced PD per RECIST v1.1 or unacceptable toxicity in Stage 1 and chose to continue treatment in Stage 2 received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and tiragolumab, 600 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit, as determined by the investigator (cycle length=21 days). After Stage 2, participants entered the LTSFU.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Leukostasis syndrome
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
3/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
33.3%
4/12 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
4/13 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
26.1%
6/23 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
41.5%
27/65 • Number of events 34 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
32.3%
20/62 • Number of events 28 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
28.6%
4/14 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
17.4%
4/23 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.5%
14/65 • Number of events 21 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.5%
9/62 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
2/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.9%
11/65 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.1%
5/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.7%
6/62 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Eye disorders
Diplopia
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Eye disorders
Photopsia
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Eye disorders
Vitreous floaters
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
33.3%
4/12 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
4/13 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
10.8%
7/65 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.7%
6/62 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.0%
3/23 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
4/13 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
4/13 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
43.5%
10/23 • Number of events 14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
40.0%
26/65 • Number of events 34 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
37.1%
23/62 • Number of events 30 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
3/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
25.0%
3/12 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.7%
5/23 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
27.7%
18/65 • Number of events 27 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
50.0%
31/62 • Number of events 44 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.0%
3/23 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.1%
5/62 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Dysphagia
|
40.0%
2/5 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
17.4%
4/23 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
24.2%
15/62 • Number of events 21 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Gastric ulcer
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.8%
9/65 • Number of events 11 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.0%
3/23 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.3%
8/65 • Number of events 11 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.7%
6/62 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
25.0%
3/12 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
4/13 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
78.3%
18/23 • Number of events 29 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
78.5%
51/65 • Number of events 84 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
79.0%
49/62 • Number of events 68 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Oesophageal compression
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Sicca syndrome
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
26.1%
6/23 • Number of events 22 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
20/65 • Number of events 26 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
35.5%
22/62 • Number of events 24 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.0%
3/23 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
24.6%
16/65 • Number of events 28 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
32.3%
20/62 • Number of events 23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
25.0%
3/12 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.3%
8/65 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
17.7%
11/62 • Number of events 14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Catheter site pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Chest discomfort
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Chest pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Early satiety
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
33.3%
4/12 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
34.8%
8/23 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
47.7%
31/65 • Number of events 45 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.6%
19/62 • Number of events 25 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Feeling cold
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Injection site pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Injection site reaction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
38.5%
5/13 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Malaise
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
17.4%
4/23 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
27.7%
18/65 • Number of events 25 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.5%
9/62 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
4/13 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
11.3%
7/62 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
25.0%
3/12 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
4/13 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.0%
3/23 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
20.0%
13/65 • Number of events 21 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.0%
13/62 • Number of events 24 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
General disorders
Temperature intolerance
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 36 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
20.0%
13/65 • Number of events 13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.7%
6/62 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Candida infection
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Cellulitis
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Device related infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Septic shock
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Tonsillitis
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.7%
6/62 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
69.2%
9/13 • Number of events 15 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
11.3%
7/62 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Amylase increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.2%
6/65 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.7%
6/62 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Blood folate decreased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Blood creatine increased
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
40.0%
2/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Blood creatinine increased
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.9%
11/65 • Number of events 13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
11.3%
7/62 • Number of events 13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.3%
8/65 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
50.0%
6/12 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
43.5%
10/23 • Number of events 15 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
18.5%
12/65 • Number of events 16 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
27.4%
17/62 • Number of events 29 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.4%
7/23 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.3%
8/65 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
22.6%
14/62 • Number of events 18 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Weight decreased
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.8%
4/13 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
10/65 • Number of events 11 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
19.4%
12/62 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
Weight increased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Investigations
White blood cell count decreased
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
26.1%
6/23 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.3%
8/65 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.9%
8/62 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
5/5 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
50.0%
6/12 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
46.2%
6/13 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
38.5%
5/13 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
42.9%
6/14 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
65.2%
15/23 • Number of events 21 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
52.3%
34/65 • Number of events 51 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
53.2%
33/62 • Number of events 41 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
11.3%
7/62 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
17.4%
4/23 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.3%
8/65 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
33.9%
21/62 • Number of events 30 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
17.4%
4/23 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
15/65 • Number of events 34 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
22.6%
14/62 • Number of events 25 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.0%
3/23 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.9%
11/65 • Number of events 16 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.1%
10/62 • Number of events 18 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.1%
5/62 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
38.5%
5/13 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.1%
5/62 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
60.0%
3/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.9%
11/65 • Number of events 13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.5%
9/62 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
3/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.1%
5/62 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
10/65 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.0%
13/62 • Number of events 13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Dysgeusia
|
40.0%
2/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.2%
6/65 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.7%
6/62 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Migraine
|
20.0%
1/5 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
40.0%
2/5 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
25.0%
3/12 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
18.5%
12/65 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.5%
9/62 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
60.0%
3/5 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
34.8%
8/23 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
10.8%
7/65 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Product Issues
Device malfunction
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 11 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Product Issues
Device occlusion
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 19 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.0%
3/23 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
18.5%
12/65 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.9%
8/62 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
9.7%
6/62 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
20.0%
13/65 • Number of events 14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.9%
8/62 • Number of events 9 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 11 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
33.3%
4/12 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
10/65 • Number of events 11 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.5%
4/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.1%
10/62 • Number of events 10 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
13.8%
9/65 • Number of events 15 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
33.3%
4/12 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.7%
5/23 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
10.8%
7/65 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
12.9%
8/62 • Number of events 8 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
60.0%
3/5 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.1%
5/62 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
17.4%
4/23 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.9%
11/65 • Number of events 12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
30.6%
19/62 • Number of events 25 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
28.6%
4/14 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.6%
3/65 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
23.1%
15/65 • Number of events 17 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
35.5%
22/62 • Number of events 23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
21.4%
3/14 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.8%
3/62 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.3%
1/12 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin oedema
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
11.3%
7/62 • Number of events 7 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
4.3%
1/23 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
5/65 • Number of events 6 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Embolism venous
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
16.7%
2/12 • Number of events 3 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.7%
1/13 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
8.7%
2/23 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.1%
2/65 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
3.2%
2/62 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
15.4%
2/13 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
6.2%
4/65 • Number of events 4 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.6%
1/62 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
7.1%
1/14 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/5 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
1.5%
1/65 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
14.3%
2/14 • Number of events 2 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
|
Vascular disorders
Subclavian vein embolism
|
20.0%
1/5 • Number of events 1 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/12 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/13 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/23 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/65 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/62 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
0.00%
0/14 • Stage 1: Up to 84.2 months; Stage 2: Up to 42.6 months
All AEs: SE population included all randomized participants who received any amount of study treatment. All-cause Mortality: All randomized population included all randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER