Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (NCT NCT03869190)
NCT ID: NCT03869190
Last Updated: 2026-08-03
Results Overview
ORR was defined as the percentage of participants with an objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart during Stage 1, as determined by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, 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. Percentages have been rounded off.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
272 participants
Primary outcome timeframe
Up to 61.5 months
Results posted on
2026-08-03
Participant Flow
A total of 272 participants with muscle-invasive bladder cancer (MIBC) or locally advanced or metastatic urothelial carcinoma (mUC) who had progressed during or following a platinum-containing regimen took part in the study across 7 countries from 01 June 2019 to 22 December 2025.
Results include only those cohorts that enrolled participants; planned cohorts that were never opened for enrollment are not presented.
Participant milestones
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
Participants received atezolizumab (atezo), 1200 milligrams (mg), intravenously (IV) on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up (LTSFU) (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin (EV), 1.25 milligrams per kilogram (mg/kg), IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib (Nira), 200 mg, orally (PO), once daily (QD) until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan (SG), 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab (TCZ), 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 MIBC Cohort 1: Atezo (Control)
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 1: Atezo + Tira
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo (Control)
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo + Tira
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis (Control)
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV on Day 1, followed by gemcitabine, 1000 milligrams per square meter (mg/m\^2), IV on Days 1 and 8, and cisplatin, 70 mg/m\^2, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis + Tira
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV and tiragolumab, 600 mg, IV on Day 1, followed by gemcitabine, 1000 mg/m\^2 on Days 1 and 8, and cisplatin, 70 mg/m\^2 on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
30
|
15
|
16
|
15
|
12
|
15
|
31
|
15
|
6
|
11
|
23
|
47
|
18
|
18
|
0
|
0
|
|
Stage 1
Safety-evaluable (SE) Population
|
29
|
15
|
15
|
15
|
12
|
15
|
30
|
15
|
6
|
11
|
23
|
46
|
18
|
17
|
0
|
0
|
|
Stage 1
COMPLETED
|
28
|
12
|
15
|
13
|
11
|
13
|
27
|
15
|
5
|
9
|
20
|
41
|
16
|
15
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
2
|
3
|
1
|
2
|
1
|
2
|
4
|
0
|
1
|
2
|
3
|
6
|
2
|
3
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
15
|
|
Stage 2
SE Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
15
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
11
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Long-term Survival Follow-up (LTSFU)
STARTED
|
17
|
11
|
13
|
8
|
9
|
13
|
21
|
11
|
5
|
9
|
20
|
41
|
16
|
15
|
15
|
11
|
|
Long-term Survival Follow-up (LTSFU)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
7
|
5
|
5
|
0
|
0
|
|
Long-term Survival Follow-up (LTSFU)
NOT COMPLETED
|
17
|
11
|
13
|
8
|
9
|
13
|
21
|
11
|
5
|
6
|
17
|
34
|
11
|
10
|
15
|
11
|
Reasons for withdrawal
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
Participants received atezolizumab (atezo), 1200 milligrams (mg), intravenously (IV) on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up (LTSFU) (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin (EV), 1.25 milligrams per kilogram (mg/kg), IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib (Nira), 200 mg, orally (PO), once daily (QD) until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan (SG), 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab (TCZ), 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 MIBC Cohort 1: Atezo (Control)
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 1: Atezo + Tira
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo (Control)
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo + Tira
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis (Control)
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV on Day 1, followed by gemcitabine, 1000 milligrams per square meter (mg/m\^2), IV on Days 1 and 8, and cisplatin, 70 mg/m\^2, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis + Tira
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV and tiragolumab, 600 mg, IV on Day 1, followed by gemcitabine, 1000 mg/m\^2 on Days 1 and 8, and cisplatin, 70 mg/m\^2 on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage 1
Death
|
1
|
3
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
1
|
1
|
4
|
2
|
1
|
0
|
0
|
|
Stage 1
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
2
|
1
|
0
|
1
|
0
|
0
|
|
Stage 1
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Reason not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Stage 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Long-term Survival Follow-up (LTSFU)
Reason not Specified
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
1
|
|
Long-term Survival Follow-up (LTSFU)
Death
|
12
|
10
|
8
|
6
|
7
|
8
|
16
|
10
|
1
|
1
|
7
|
13
|
3
|
1
|
11
|
9
|
|
Long-term Survival Follow-up (LTSFU)
Arm Terminated by Sponsor
|
0
|
1
|
3
|
1
|
2
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
1
|
|
Long-term Survival Follow-up (LTSFU)
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
7
|
0
|
0
|
0
|
0
|
|
Long-term Survival Follow-up (LTSFU)
Study Terminated by Sponsor
|
2
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
4
|
4
|
8
|
10
|
7
|
9
|
0
|
0
|
|
Long-term Survival Follow-up (LTSFU)
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Long-term Survival Follow-up (LTSFU)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Baseline characteristics by cohort
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=30 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=16 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=31 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 Participants
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 MIBC Cohort 1: Atezo (Control)
n=6 Participants
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 1: Atezo + Tira
n=11 Participants
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo (Control)
n=23 Participants
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo + Tira
n=47 Participants
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis (Control)
n=18 Participants
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV on Day 1, followed by gemcitabine, 1000 milligrams per square meter (mg/m\^2), IV on Days 1 and 8, and cisplatin, 70 mg/m\^2, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis + Tira
n=18 Participants
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV and tiragolumab, 600 mg, IV on Day 1, followed by gemcitabine, 1000 mg/m\^2 on Days 1 and 8, and cisplatin, 70 mg/m\^2 on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Stage 1 · Adults (18-64 years)
|
8 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
11 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
9 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
5 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
3 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
5 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
8 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
79 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Age, Customized
Stage 1 · From 65-84 years
|
21 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
9 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
8 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
9 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
20 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
9 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
18 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
44 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
13 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
191 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Age, Customized
Stage 1 · 85 years and over
|
1 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
2 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Age, Customized
Stage 2 · Adults (18-64 years)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
8 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Age, Customized
Stage 2 · From 65-84 years
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
21 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Age, Customized
Stage 2 · 85 years and over
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Sex: Female, Male
Stage 1 · Female
|
5 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
6 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
5 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
3 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
56 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Sex: Female, Male
Stage 1 · Male
|
25 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
8 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
25 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
5 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
9 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
18 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
37 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
16 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
15 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
216 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Sex: Female, Male
Stage 2 · Female
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
8 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Sex: Female, Male
Stage 2 · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
22 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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
|
1 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
16 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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
|
27 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
25 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
23 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
44 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
16 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
14 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
237 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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
|
2 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
5 Participants
n=16 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
19 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
28 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
0 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · Asian
|
8 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
4 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
5 Participants
n=16 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
9 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
7 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
51 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
1 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
3 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 1 · White
|
20 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
8 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
16 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
5 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
10 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
22 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
36 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
17 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
18 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
193 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
0 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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
|
2 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
5 Participants
n=16 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=12 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
6 Participants
n=31 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=6 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
1 Participants
n=11 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=23 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=47 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=18 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
—
|
—
|
24 Participants
n=272 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
7 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
|
Race (NIH/OMB)
Stage 2 · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
21 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
0 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=15 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, 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 loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
2 Participants
n=30 Participants • Number analyzed is the number of participants who experienced loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
|
PRIMARY outcome
Timeframe: Up to 61.5 monthsPopulation: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
ORR was defined as the percentage of participants with an objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart during Stage 1, as determined by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, 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. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=29 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=30 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 Participants
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 mUC Cohorts: Objective Response Rate (ORR)
|
27.6 percentage of participants
Interval 12.73 to 47.24
|
26.7 percentage of participants
Interval 7.79 to 55.1
|
26.7 percentage of participants
Interval 7.79 to 55.1
|
6.7 percentage of participants
Interval 0.17 to 31.95
|
16.7 percentage of participants
Interval 2.09 to 48.41
|
6.7 percentage of participants
Interval 0.17 to 31.95
|
20.0 percentage of participants
Interval 7.71 to 38.57
|
20.0 percentage of participants
Interval 4.33 to 48.09
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17.8 monthsPopulation: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
pCR was defined as the percentage of participants with an absence of residual invasive cancer of the complete resected specimen. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=6 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=11 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=23 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=45 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=18 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=17 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MIBC Cohorts: Pathological Complete Response (pCR)
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
27.3 percentage of participants
Interval 6.02 to 60.97
|
21.7 percentage of participants
Interval 7.46 to 43.7
|
20.0 percentage of participants
Interval 9.58 to 34.6
|
27.8 percentage of participants
Interval 9.69 to 53.48
|
23.5 percentage of participants
Interval 6.81 to 49.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to PD or death from any cause, whichever occurred first (up to 62 months)Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
PFS after randomization was defined as the time from randomization to the first occurrence of disease progression (PD) or death from any cause, whichever occurred first in Stage 1, 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 SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. PFS for participants with no documented PD or death was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate the median PFS.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=29 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=30 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 Participants
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 mUC Cohorts: Progression-free Survival (PFS) After Randomization
|
6.05 months
Interval 3.52 to 10.18
|
4.47 months
Interval 3.45 to 6.24
|
2.32 months
Interval 1.97 to 10.51
|
2.23 months
Interval 2.0 to 2.99
|
3.06 months
Interval 2.1 to 14.32
|
3.48 months
Interval 2.14 to 8.28
|
3.14 months
Interval 2.1 to 4.86
|
4.07 months
Interval 2.27 to 8.34
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to death from any cause (up to 69.1 months)Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
OS after randomization was defined as the time from randomization to death from any cause. Data for participants who had not died were censored at the last date they were known to be alive. K-M method was used to estimate the median OS.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=29 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=30 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 Participants
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 mUC Cohorts: Overall Survival (OS) After Randomization
|
18.79 months
Interval 10.64 to 31.54
|
6.83 months
Interval 5.62 to 10.68
|
21.82 months
Interval 7.2 to
Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
|
8.57 months
Interval 5.16 to 35.45
|
7.33 months
Interval 4.34 to 16.66
|
14.55 months
Interval 8.25 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
12.32 months
Interval 4.4 to 34.86
|
6.28 months
Interval 5.13 to 19.88
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 12Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
OS rate at Month 12 was defined as percentage of participants who did not experience death from any cause at the specified timepoint. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=29 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=30 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 Participants
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 mUC Cohorts: OS Rate at Month 12
|
64.77 percentage of participants
Interval 47.15 to 82.39
|
26.67 percentage of participants
Interval 4.29 to 49.05
|
61.90 percentage of participants
Interval 35.56 to 88.25
|
39.16 percentage of participants
Interval 12.54 to 65.78
|
36.36 percentage of participants
Interval 7.94 to 64.79
|
61.90 percentage of participants
Interval 35.56 to 88.25
|
52.94 percentage of participants
Interval 34.95 to 70.93
|
40.00 percentage of participants
Interval 15.21 to 64.79
|
—
|
—
|
SECONDARY outcome
Timeframe: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to 61.5 months)Population: Efficacy-evaluable 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 an OR.
DOR was defined as the time from the first occurrence of a documented OR (CR or PR) during Stage 1 to PD or death from any cause during Stage 1, whichever occurred first, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the median DOR.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=8 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=4 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=4 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=1 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=2 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=1 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=6 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=3 Participants
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 mUC Cohorts: Duration of Response (DOR)
|
32.16 months
Interval 6.24 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
8.66 months
Interval 4.07 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
NA months
Interval 8.34 to
Median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
|
13.11 months
95% CI was not estimable due to insufficient number of participants with events.
|
NA months
Median and 95% CI were not estimable due to insufficient number of participants with events.
|
21.42 months
95% CI was not estimable due to insufficient number of participants with events.
|
42.74 months
Interval 21.62 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
11.43 months
Interval 6.24 to
Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 61.5 monthsPopulation: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
DCR was defined as percentage of participants with stable disease for ≥ 18 weeks or an OR (CR or PR) during Stage 1, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage of target lesions to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=29 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=30 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 Participants
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 mUC Cohorts: Disease Control Rate (DCR)
|
48.3 percentage of participants
Interval 29.45 to 67.47
|
40.0 percentage of participants
Interval 16.34 to 67.71
|
26.7 percentage of participants
Interval 7.79 to 55.1
|
13.3 percentage of participants
Interval 1.66 to 40.46
|
25.0 percentage of participants
Interval 5.49 to 57.19
|
33.3 percentage of participants
Interval 11.82 to 61.62
|
30.0 percentage of participants
Interval 14.73 to 49.4
|
26.7 percentage of participants
Interval 7.79 to 55.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Up to 62.1 months; Stage 2: Up to 18.3 monthsPopulation: SE population included all participants who received any amount of study treatment.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=29 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=30 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 Participants
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
n=15 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
n=15 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stages 1 and 2 mUC Cohorts: Number of Participants With Adverse Events (AEs)
|
29 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
12 Participants
|
15 Participants
|
30 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Predose: Day 1 of Cycles 1, 2 and 4; 30 minutes postdose: Day 1 Cycle 1Population: Atezolizumab pharmacokinetic (PK)-evaluable population included all randomized participants who received at least one dose of atezolizumab.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=5 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2 mUC [Atezo + EV Cohort]: Serum Concentration of Atezolizumab at Specified Timepoints
Predose: Cycle 1 Day 1
|
107 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 60.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 2 mUC [Atezo + EV Cohort]: Serum Concentration of Atezolizumab at Specified Timepoints
30 min Postdose: Cycle 1 Day 1
|
390 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 25.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 2 mUC [Atezo + EV Cohort]: Serum Concentration of Atezolizumab at Specified Timepoints
Predose: Cycle 2 Day 1
|
105 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 57.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 2 mUC [Atezo + EV Cohort]: Serum Concentration of Atezolizumab at Specified Timepoints
Predose: Cycle 4 Day 1
|
121 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 43.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 18.3 monthsPopulation: Immunogenicity analysis population included all participants with at least one ADA assessment.
Participants 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 unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=8 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2 mUC [Atezo + EV Cohort]: Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Months 12, 18, and 24Population: Pathologic response evaluable population included all participants who achieved pCR.
Landmark RFS was defined as the percentage of participants who were alive without disease recurrence at specified timepoints following surgery. RFS was defined as the time from Day 1 in the first cycle after surgery to the first documented recurrence of disease or death from any cause. RFS rates at the specified landmark timepoints were estimated using the K-M method.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=5 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=8 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=38 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=15 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=14 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MIBC Cohorts: Landmark Recurrence-free Survival (RFS) Rate
Month 24
|
NA percentage of participants
Number and 95% CI were not estimable due to an insufficient number of participants reaching the landmark of 24 months.
|
66.67 percentage of participants
Interval 28.95 to 100.0
|
68.18 percentage of participants
Interval 37.26 to 99.1
|
57.70 percentage of participants
Interval 37.26 to 78.14
|
70.00 percentage of participants
Interval 41.6 to 98.4
|
81.48 percentage of participants
Interval 58.08 to 100.0
|
—
|
—
|
—
|
—
|
|
MIBC Cohorts: Landmark Recurrence-free Survival (RFS) Rate
Month 12
|
100.00 percentage of participants
Interval 100.0 to 100.0
|
66.67 percentage of participants
Interval 28.95 to 100.0
|
81.82 percentage of participants
Interval 59.03 to 100.0
|
68.00 percentage of participants
Interval 49.71 to 86.29
|
80.00 percentage of participants
Interval 55.21 to 100.0
|
100.00 percentage of participants
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
|
MIBC Cohorts: Landmark Recurrence-free Survival (RFS) Rate
Month 18
|
NA percentage of participants
Number and 95% CI were not estimable due to an insufficient number of participants reaching the landmark of 18 months.
|
66.67 percentage of participants
Interval 28.95 to 100.0
|
68.18 percentage of participants
Interval 37.26 to 99.1
|
63.47 percentage of participants
Interval 44.36 to 82.57
|
80.00 percentage of participants
Interval 55.21 to 100.0
|
91.67 percentage of participants
Interval 76.03 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Months 12, 18, and 24Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
Landmark EFS was defined as the percentage of participants who were alive without experiencing a predefined event at specified timepoints. EFS was defined as the time from randomization to any of the following events, whichever occurred first: PD that precludes surgery, as assessed by the investigator; local or distant disease recurrence; or death from any cause. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. EFS rates at the specified landmark timepoints were estimated using the K-M method.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=6 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=11 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=23 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=46 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=18 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=17 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MIBC Cohorts: Landmark Event-free Survival (EFS) Rate
Month 12
|
83.33 percentage of participants
Interval 53.51 to 100.0
|
75.00 percentage of participants
Interval 44.99 to 100.0
|
73.68 percentage of participants
Interval 53.88 to 93.48
|
61.13 percentage of participants
Interval 46.23 to 76.04
|
59.58 percentage of participants
Interval 36.21 to 82.96
|
92.86 percentage of participants
Interval 79.37 to 100.0
|
—
|
—
|
—
|
—
|
|
MIBC Cohorts: Landmark Event-free Survival (EFS) Rate
Month 18
|
83.33 percentage of participants
Interval 53.51 to 100.0
|
75.00 percentage of participants
Interval 44.99 to 100.0
|
60.79 percentage of participants
Interval 37.72 to 83.86
|
56.24 percentage of participants
Interval 41.06 to 71.42
|
59.58 percentage of participants
Interval 36.21 to 82.96
|
85.12 percentage of participants
Interval 66.05 to 100.0
|
—
|
—
|
—
|
—
|
|
MIBC Cohorts: Landmark Event-free Survival (EFS) Rate
Month 24
|
83.33 percentage of participants
Interval 53.51 to 100.0
|
75.00 percentage of participants
Interval 44.99 to 100.0
|
45.59 percentage of participants
Interval 20.45 to 70.73
|
49.32 percentage of participants
Interval 33.23 to 65.42
|
52.96 percentage of participants
Interval 28.85 to 77.07
|
85.12 percentage of participants
Interval 66.05 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Months 12, 18, and 24Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.
Landmark OS was defined as the percentage of participants who were alive at specified timepoints. OS was defined as the time from randomization to death from any cause. OS rates at the specified landmark timepoints were estimated using the K-M method.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=6 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=11 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=23 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=46 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=18 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=17 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MIBC Cohorts: Landmark OS Rate
Month 12
|
83.33 percentage of participants
Interval 53.51 to 100.0
|
88.89 percentage of participants
Interval 68.36 to 100.0
|
76.22 percentage of participants
Interval 57.95 to 94.5
|
75.01 percentage of participants
Interval 62.18 to 87.84
|
77.78 percentage of participants
Interval 58.57 to 96.98
|
93.75 percentage of participants
Interval 81.89 to 100.0
|
—
|
—
|
—
|
—
|
|
MIBC Cohorts: Landmark OS Rate
Month 18
|
83.33 percentage of participants
Interval 53.51 to 100.0
|
88.89 percentage of participants
Interval 68.36 to 100.0
|
64.88 percentage of participants
Interval 43.59 to 86.17
|
67.98 percentage of participants
Interval 54.1 to 81.86
|
72.22 percentage of participants
Interval 51.53 to 92.91
|
93.75 percentage of participants
Interval 81.89 to 100.0
|
—
|
—
|
—
|
—
|
|
MIBC Cohorts: Landmark OS Rate
Month 24
|
83.33 percentage of participants
Interval 53.51 to 100.0
|
88.89 percentage of participants
Interval 68.36 to 100.0
|
58.39 percentage of participants
Interval 35.75 to 81.04
|
61.83 percentage of participants
Interval 46.77 to 76.88
|
72.22 percentage of participants
Interval 51.53 to 92.91
|
87.50 percentage of participants
Interval 71.3 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 17.8 monthsPopulation: SE population included all participants who received any amount of study treatment.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=6 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=11 Participants
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=23 Participants
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=46 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=18 Participants
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + SG
n=17 Participants
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 2 mUC Cohort: Atezo + EV
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
MIBC Cohorts: Number of Participants With AEs
|
6 Participants
|
11 Participants
|
23 Participants
|
45 Participants
|
18 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1 mUC Cohort: Atezo (Control)
Serious events: 11 serious events
Other events: 29 other events
Deaths: 13 deaths
Stage 1 mUC Cohort: Atezo + EV
Serious events: 9 serious events
Other events: 14 other events
Deaths: 13 deaths
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
Serious events: 8 serious events
Other events: 14 other events
Deaths: 8 deaths
Stage 1 mUC Cohort: Atezo + Nira
Serious events: 7 serious events
Other events: 15 other events
Deaths: 8 deaths
Stage 1 mUC Cohort: Atezo + RO7122290
Serious events: 9 serious events
Other events: 11 other events
Deaths: 7 deaths
Stage 1 Cohort 1 mUC Atezo+SG
Serious events: 9 serious events
Other events: 14 other events
Deaths: 9 deaths
Stage 1 mUC Cohort: Atezo + Tira
Serious events: 12 serious events
Other events: 30 other events
Deaths: 19 deaths
Stage 1 mUC Cohort: Atezo + TCZ
Serious events: 8 serious events
Other events: 14 other events
Deaths: 10 deaths
Stage 1 MIBC Cohort 1: Atezo (Control)
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Stage 1 MIBC Cohort 1: Atezo + Tira
Serious events: 6 serious events
Other events: 11 other events
Deaths: 2 deaths
Stage 1 MIBC Cohort 2: Atezo (Control)
Serious events: 14 serious events
Other events: 22 other events
Deaths: 8 deaths
Stage 1 MIBC Cohort 2: Atezo + Tira
Serious events: 35 serious events
Other events: 41 other events
Deaths: 17 deaths
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis (Control)
Serious events: 10 serious events
Other events: 18 other events
Deaths: 5 deaths
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis + Tira
Serious events: 10 serious events
Other events: 16 other events
Deaths: 2 deaths
Stage 2 mUC Cohort: Atezo + EV
Serious events: 8 serious events
Other events: 15 other events
Deaths: 11 deaths
Stage 2 mUC Cohort: Atezo + SG
Serious events: 10 serious events
Other events: 15 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=29 participants at risk
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 participants at risk
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 participants at risk
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 participants at risk
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 participants at risk
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 Cohort 1 mUC Atezo+SG
n=15 participants at risk
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=30 participants at risk
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 participants at risk
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 MIBC Cohort 1: Atezo (Control)
n=6 participants at risk
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 1: Atezo + Tira
n=11 participants at risk
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo (Control)
n=23 participants at risk
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo + Tira
n=46 participants at risk
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis (Control)
n=18 participants at risk
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV on Day 1, followed by gemcitabine, 1000 milligrams per square meter (mg/m\^2), IV on Days 1 and 8, and cisplatin, 70 mg/m\^2, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis + Tira
n=17 participants at risk
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV and tiragolumab, 600 mg, IV on Day 1, followed by gemcitabine, 1000 mg/m\^2 on Days 1 and 8, and cisplatin, 70 mg/m\^2 on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + EV
n=15 participants at risk
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
n=15 participants at risk
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Acquired amegakaryocytic thrombocytopenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Asthenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Chest pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Death
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Fatigue
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Malaise
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Physical deconditioning
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Prosthetic cardiac valve thrombosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Pyrexia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Abscess limb
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Bacillus Calmette-Guerin infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
COVID-19
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Infected fistula
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
27.3%
3/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Septic shock
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Ureteritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
36.4%
4/11 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
4/23 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
8/46 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
35.3%
6/17 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Immune-mediated myasthenia gravis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Seizure
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Transient ischaemic attack
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
2/6 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
19.6%
9/46 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Hydronephrosis
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Amylase increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Platelet count decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Troponin increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
3.4%
1/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Distributive shock
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Embolism
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
Other adverse events
| Measure |
Stage 1 mUC Cohort: Atezo (Control)
n=29 participants at risk
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + EV
n=15 participants at risk
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Hu5F9-G4
n=15 participants at risk
Participants received atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle, and magrolimab (Hu5F9-G4), as IV infusion, at a dose of 1 mg/kg on Day 1 of Cycle 1, and 30 mg/kg on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2; Days 1 and 15 of all subsequent cycles until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 mUC Cohort: Atezo + Nira
n=15 participants at risk
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by niraparib, 200 mg, PO, QD until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + RO7122290
n=12 participants at risk
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by RO7122290 (FAP-4-1BBL), 250 mg, IV on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 Cohort 1 mUC Atezo+SG
n=15 participants at risk
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + Tira
n=30 participants at risk
Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by tiragolumab, 600 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=21 days).
|
Stage 1 mUC Cohort: Atezo + TCZ
n=15 participants at risk
Participants received tocilizumab, 8 mg/kg, IV on Day 1 of each cycle, followed by atezolizumab, 840 mg, IV on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 1, participants who did not enter Stage 2 entered the LTSFU (1 Cycle=28 days).
|
Stage 1 MIBC Cohort 1: Atezo (Control)
n=6 participants at risk
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 1: Atezo + Tira
n=11 participants at risk
Participants with cisplatin-ineligible MIBC and PD-L1-positive expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo (Control)
n=23 participants at risk
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 2: Atezo + Tira
n=46 participants at risk
Participants with cisplatin-ineligible MIBC and PD-L1-negative expression status received atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, as IV infusions on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis (Control)
n=18 participants at risk
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV on Day 1, followed by gemcitabine, 1000 milligrams per square meter (mg/m\^2), IV on Days 1 and 8, and cisplatin, 70 mg/m\^2, IV on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 1 MIBC Cohort 3: Gem + Atezo + Cis + Tira
n=17 participants at risk
Participants with cisplatin-eligible MIBC, regardless of PD-L1 expression status, received atezolizumab, 1200 mg, IV and tiragolumab, 600 mg, IV on Day 1, followed by gemcitabine, 1000 mg/m\^2 on Days 1 and 8, and cisplatin, 70 mg/m\^2 on Day 1 of Cycles 1 to 3. Participants underwent surgery after Cycle 3, and treatment with atezolizumab and tiragolumab was reinitiated in Cycle 4 approximately 4-6 weeks after surgery and continued for up to a maximum of 17 cycles (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + EV
n=15 participants at risk
Participants received enfortumab vedotin, 1.25 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
Stage 2 mUC Cohort: Atezo + SG
n=15 participants at risk
Participants received sacituzumab govitecan, 10 mg/kg, IV on Days 1 and 8 of each cycle, followed by atezolizumab, 1200 mg, IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After completing Stage 2, participants entered the LTSFU (1 Cycle=21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.7%
6/29 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
53.3%
8/15 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
46.7%
7/15 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
66.7%
10/15 • Number of events 14 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
10.0%
3/30 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
36.4%
4/11 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.1%
6/23 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
34.8%
16/46 • Number of events 23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
55.6%
10/18 • Number of events 15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
58.8%
10/17 • Number of events 12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
46.7%
7/15 • Number of events 14 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.8%
4/29 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
5/30 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Hypofibrinogenaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
22.2%
4/18 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.6%
3/17 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Ear and labyrinth disorders
Vertigo
|
6.9%
2/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Endocrine disorders
Hyperthyroidism
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Endocrine disorders
Hypothyroidism
|
13.8%
4/29 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
4/30 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Blepharitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Cataract
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Diplopia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Dry eye
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Episcleritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Vision blurred
|
6.9%
2/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Visual impairment
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.8%
4/29 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
10.0%
3/30 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
15.2%
7/46 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Anal rash
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Constipation
|
10.3%
3/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
8/30 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.1%
6/23 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.1%
12/46 • Number of events 14 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
44.4%
8/18 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
29.4%
5/17 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
3/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.3%
7/30 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
8/46 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
38.9%
7/18 • Number of events 12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
29.4%
5/17 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.5%
4/17 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Food poisoning
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Haematochezia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
46.7%
7/15 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
10/30 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
4/23 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.9%
11/46 • Number of events 18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
50.0%
9/18 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
58.8%
10/17 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Toothache
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
25.0%
3/12 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.3%
7/30 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
22.2%
4/18 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.6%
3/17 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Asthenia
|
13.8%
4/29 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
25.0%
3/12 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
30.0%
9/30 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
27.8%
5/18 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
41.2%
7/17 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Catheter site discomfort
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Chest pain
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Chills
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
8/46 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Discomfort
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Face oedema
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Fatigue
|
20.7%
6/29 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
46.7%
7/15 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
25.0%
3/12 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
46.7%
14/30 • Number of events 14 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
2/6 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
34.8%
8/23 • Number of events 13 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
43.5%
20/46 • Number of events 28 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
50.0%
9/18 • Number of events 17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
41.2%
7/17 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 13 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Gait disturbance
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Hyperthermia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Influenza like illness
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Malaise
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Mucosal discolouration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Oedema
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Oedema peripheral
|
10.3%
3/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
8/46 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
3/18 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Performance status decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Peripheral swelling
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Pyrexia
|
10.3%
3/29 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
4/30 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
27.3%
3/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
15.2%
7/46 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
22.2%
4/18 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.6%
3/17 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Swelling
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Swelling face
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
General disorders
Temperature intolerance
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
COVID-19
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
3/18 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.5%
4/17 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Cystitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Device related infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Groin infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Influenza
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Otitis media
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Respiratory tract infection
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Scabies
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Skin infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
17.2%
5/29 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.3%
7/30 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
27.3%
3/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
30.4%
7/23 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
30.4%
14/46 • Number of events 22 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
22.2%
4/18 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
47.1%
8/17 • Number of events 14 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Aldolase increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Inappropriate schedule of product administration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Incorrect product administration duration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
15.2%
7/46 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Stoma site pruritus
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Stoma site rash
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 13 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
8/46 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Amylase increased
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Aspartate aminotransferase increased
|
6.9%
2/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
8/46 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood bilirubin increased
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood creatinine increased
|
20.7%
6/29 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
4/30 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
50.0%
3/6 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
19.6%
9/46 • Number of events 18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
27.8%
5/18 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.6%
3/17 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Blood urea increased
|
10.3%
3/29 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Heart rate increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Lipase increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
2/6 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.6%
3/17 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Platelet count decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
3/18 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Urine output decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Vitamin B12 increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Weight decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
21.7%
5/23 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
6/46 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
Weight increased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.1%
7/29 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
53.3%
8/15 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
4/12 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.3%
7/30 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.9%
11/46 • Number of events 15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
6/18 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.6%
3/17 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Gout
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
3/18 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.9%
2/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
10.9%
5/46 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
21.7%
5/23 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
4/23 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
3/18 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.6%
3/17 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.3%
3/29 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
6/30 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
4/23 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
3/29 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
25.0%
3/12 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
6/30 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.9%
11/46 • Number of events 15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
27.3%
3/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
3/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
3.4%
1/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
4/23 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Dysgeusia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
27.8%
5/18 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
25.0%
3/12 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
27.3%
3/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Migraine
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Paraesthesia
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
4/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Presyncope
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Sciatica
|
6.9%
2/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Tremor
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Anhedonia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
2/12 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Depression
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Insomnia
|
6.9%
2/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
10.9%
5/46 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
4/30 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
2/6 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Haematuria
|
13.8%
4/29 • Number of events 8 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
10.0%
3/30 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
4/23 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
19.6%
9/46 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Proteinuria
|
6.9%
2/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
5/30 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
2/6 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
23.9%
11/46 • Number of events 13 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
10.0%
3/30 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
3/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 7 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
2/6 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
60.0%
9/15 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
40.0%
6/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.3%
3/29 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
2/46 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
24.1%
7/29 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 10 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
4/12 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
46.7%
7/15 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
10/30 • Number of events 12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
81.8%
9/11 • Number of events 12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.4%
4/23 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
34.8%
16/46 • Number of events 25 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.1%
2/18 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
35.3%
6/17 • Number of events 14 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
5/15 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
4/30 • Number of events 6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.2%
5/29 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
3/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
33.3%
4/12 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
26.7%
4/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
20.0%
6/30 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
45.5%
5/11 • Number of events 5 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.7%
2/23 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
37.0%
17/46 • Number of events 21 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
3/18 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
35.3%
6/17 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
53.3%
8/15 • Number of events 9 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
18.2%
2/11 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.0%
6/46 • Number of events 11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
17.6%
3/17 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
16.7%
1/6 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.9%
2/29 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
6.9%
2/29 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Surgical and medical procedures
Cyst removal
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Embolism
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Hot flush
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
3.3%
1/30 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Hypertension
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
13.3%
2/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 4 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.5%
3/46 • Number of events 3 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
8.3%
1/12 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
2/30 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
9.1%
1/11 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
4.3%
1/23 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
2.2%
1/46 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
11.8%
2/17 • Number of events 2 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Lymphoedema
|
3.4%
1/29 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Pallor
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.6%
1/18 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
5.9%
1/17 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/29 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/12 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/30 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
6.7%
1/15 • Number of events 1 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/6 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/11 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/23 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/46 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/18 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/17 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
0.00%
0/15 • All AEs: Stage 1 mUC cohorts: Up to 62.1 months; Stage 2 mUC cohorts: Up to 18.3 months; MIBC cohorts: Up to 17.8 months All-cause mortality: Stage 1 & Stage 2 mUC cohorts: Up to 69.1 months; MIBC cohorts: Up to 42.2 months
All AEs: SE population included all participants who received any amount of study treatment. All-cause mortality: All randomized population included all participants randomized to each treatment arm.
|
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