Trial Outcomes & Findings for A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (NCT NCT04149574)
NCT ID: NCT04149574
Last Updated: 2025-09-16
Results Overview
The time between the date of randomization and the date of first documented event or death due to any cause, whichever occurs first. Events include recurrence of disease (TaHG, T1, or CIS) and progression of disease. Data Not Collected (DNC)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
Approximately 44 Months and 1 Week
Results posted on
2025-09-16
Participant Flow
Study terminated shortly after phase 1 (safety period), phase 2 efficacy period did not initiate.
Participant milestones
| Measure |
Arm A
Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
Arm B
Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)
Baseline characteristics by cohort
| Measure |
Arm A
n=8 Participants
Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
Arm B
n=4 Participants
Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
73.0 Years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 44 Months and 1 WeekPopulation: Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion).
The time between the date of randomization and the date of first documented event or death due to any cause, whichever occurs first. Events include recurrence of disease (TaHG, T1, or CIS) and progression of disease. Data Not Collected (DNC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 44 months and 1 weekPopulation: Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion).
The time from randomization to progression to muscle-invasive disease (ie, T2), cystectomy, systemic chemotherapy, radiotherapy, or death from any cause. Data Not Collected (DNC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 44 months and 1 weekPopulation: Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion).
The time between the date of randomization and the date of death due to any cause. For participants still alive, OS is censored at the last date the participant is known to be alive. Data Not Collected (DNC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 13 WeeksPopulation: Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion).
CRR is defined as the proportion of participants with CIS (+/- TaHG/T1) per PRC at randomization who are disease free at the first disease assessment (Week 13) Data Not Collected (DNC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 44 months and 1 weekPopulation: Study terminated. Data Not Collected. Study was terminated due to slow enrollment. Decision was made to terminate study before entering phase 2 (efficacy portion).
the time between the date of the first CR to the date of first documented recurrence, progression, or death due to any cause. Data Not Collected (DNC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24.6 monthsPopulation: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria.
Outcome measures
| Measure |
Arm A
n=8 Participants
Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
Arm B
n=4 Participants
Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
|---|---|---|
|
All-causality Adverse Events Leading to Discontinuation
Any Grade
|
1 Participants
|
3 Participants
|
|
All-causality Adverse Events Leading to Discontinuation
Grade 3-4
|
0 Participants
|
0 Participants
|
|
All-causality Adverse Events Leading to Discontinuation
Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24.6 monthsPopulation: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria.
Outcome measures
| Measure |
Arm A
n=8 Participants
Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
Arm B
n=4 Participants
Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
|---|---|---|
|
All-causality Adverse Events
Grade 1
|
1 Participants
|
2 Participants
|
|
All-causality Adverse Events
Grade 2
|
4 Participants
|
1 Participants
|
|
All-causality Adverse Events
Grade 3
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24.6 monthsPopulation: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria.
Outcome measures
| Measure |
Arm A
n=8 Participants
Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
Arm B
n=4 Participants
Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
|---|---|---|
|
Drug-related Adverse Events
Grade 1
|
1 Participants
|
1 Participants
|
|
Drug-related Adverse Events
Grade 2
|
4 Participants
|
1 Participants
|
|
Drug-related Adverse Events
Grade 3
|
1 Participants
|
1 Participants
|
Adverse Events
Arm A
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=8 participants at risk
Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
Arm B
n=4 participants at risk
Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
|---|---|---|
|
Infections and infestations
Cystitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Arm A
n=8 participants at risk
Nivolumab 480 mg intravenous (IV) every 4 weeks (Q4W) for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
Arm B
n=4 participants at risk
Nivolumab-placebo IV Q4W for up to 24 months (104 weeks) and intravesical BCG (induction) weekly for 6 weeks followed by maintenance intravesical BCG weekly for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dyschezia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Drug hypersensitivity
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cystitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Skin infection
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
37.5%
3/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
75.0%
3/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Cortisol decreased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Dysuria
|
37.5%
3/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Immune-mediated cystitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Nocturia
|
25.0%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary tract disorder
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary tract obstruction
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Perineal pain
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Prostatitis
|
25.0%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 44 months and 1 week All-Cause mortality (From randomization to end of study): Approximately 44 months and 1 week
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: 1-855-907-3286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER